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TMC114/rtv
TMC114/rtv is a protease inhibitor Small molecule drug developed by Tibotec Pharmaceuticals, Ireland. It is currently in Phase 3 development for Treatment of HIV-1 infection in treatment-experienced adult patients with evidence of viral replication despite receiving an HIV-1 protease inhibitor-based regimen.
TMC114/rtv is a protease inhibitor used to treat HIV infection.
TMC114, also known as darunavir, is a medication used to treat HIV-1 infection, as well as other conditions such as COVID-19, according to ClinicalTrials.gov. It is often administered in combination with other medications, including ritonavir and etravirine, as seen in various clinical trials listed on ClinicalTrials.gov.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | TMC114/rtv |
|---|---|
| Sponsor | Tibotec Pharmaceuticals, Ireland |
| Drug class | protease inhibitor |
| Target | HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious disease |
| Phase | Phase 3 |
Mechanism of action
It works by inhibiting the protease enzyme, which is essential for the replication of the virus. This prevents the virus from producing new viral particles, thereby reducing the viral load in the body.
Approved indications
- Treatment of HIV-1 infection in treatment-experienced adult patients with evidence of viral replication despite receiving an HIV-1 protease inhibitor-based regimen
Common side effects
- Nausea
- Diarrhea
- Fatigue
- Headache
- Abdominal pain
Key clinical trials
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV (PHASE1, PHASE2)
- Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
- Population Pharmacokinetics of Antiretroviral in Children
- Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TMC114/rtv CI brief — competitive landscape report
- TMC114/rtv updates RSS · CI watch RSS
- Tibotec Pharmaceuticals, Ireland portfolio CI
Frequently asked questions about TMC114/rtv
What is TMC114/rtv?
How does TMC114/rtv work?
What is TMC114/rtv used for?
Who makes TMC114/rtv?
What drug class is TMC114/rtv in?
What development phase is TMC114/rtv in?
What are the side effects of TMC114/rtv?
What does TMC114/rtv target?
Related
- Drug class: All protease inhibitor drugs
- Target: All drugs targeting HIV protease
- Manufacturer: Tibotec Pharmaceuticals, Ireland — full pipeline
- Therapeutic area: All drugs in Infectious disease
- Indication: Drugs for Treatment of HIV-1 infection in treatment-experienced adult patients with evidence of viral replication despite receiving an HIV-1 protease inhibitor-based regimen
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing